📋 Indications & Clinical Dosage
*Treatment of complicated skin & soft-tissue infections and complicated abdominal infections caused by multiple-antibacterial resistant organisms:*
BY IV INF: Adult: Initially 100 mg, then 50 mg every 12 hours for5-14 days, Children: Not recommended.
💊 Mode of Administration
Administered by IV infusion over 30 to 60 min after dilution of the reconstituted solution in 100 ml of Dextrose 5% or NaCI 0.9 %.Reconstitute the vials with 5.3 ml of NaCI0.9% or D5W. The concentration should not exceed 1 mg/ ml. The solution should be yellow to orange.
⛔ Contraindications
Tetracycline hypersensitivity, not recommended for the treatment of foot infections in patients with diabetes. Children under 12 years (deposition in growing bone and teeth, by binding to calcium, causes staining and occasionally dental hypoplasia)
⚠️ Precautions & Warnings
Severe hepatic impairment, cholestasis, monitor for signs of acute pancreatitis, consider withdrawal if suspected, myasthenia gravis (muscle weakness may be increased), systemic lupus erythematosus (may be exacerbated), avoid exposure to sunlight or UV light, risk of super-infection.
🔄 Drug Interactions
Anticoagulants.
⚠️ Adverse Reactions / Side Effects
Abdominal pain, anorexia, bilirubinaemia, diarrhoea, dizziness, dyspepsia,
headache, hypoglycaemia, injection-site reactions, nausea, prolonged activated partial thromboplastin time, prolonged prothrombin time, pruritus, rash, vomiting, antibiotic-associated colitis, hepatic failure, Stevens-Johnson syndrome, thrombocytopenia. Rare: Cholestatic jaundice, hypoproteinaemia, pancreatitis
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Contraindicated in pregnancy.
Lactation / Breastfeeding:
Contraindicated avoid
🧪 Compatibility & Storage Stability
Compatibility: Dextrose 5%, NaCI 0.9%.
Stability & Storage: Reconstituted vial at room temperature for up to 6 hours with an additional 18 hours after dilution in the infusion solution or 48 hours in refrigerator.
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.